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Post by wyattdog on Nov 1, 2023 11:35:14 GMT -5
from uthr earnings call: "highest quarterly revenue for tyvaso dpi" "on the Tyvaso DPI supply side our partner Mannkind has completed their production expansion which we anticipate will increase production by 250% going forward." "As a reminder Mannkind is undertaking work to further expand production capacity even beyond the most recent improvements which we would expect to come online in 2024"
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Post by neil36 on Nov 1, 2023 11:39:42 GMT -5
Total Tyvaso revenue was up only 2.1% vs. last quarter. That is the head scratcher to me. Last year, 3Q Tyvaso revenue was up 28% over 2Q. In 2021, it was up 6.7% 3Q over 2Q. With the aggressive goal of rapidly expanding the patient base, a mere 2.1% increase over last quarter is definitely a disappointment. Of course, that is just dollars and we have no visibility on script numbers or possible margin compression due to insurance company pressures, etc.
But on a positive note, Tyvaso DPI represents 62.9% of Tyvaso revenue this quarter. A year ago, it represented 24.5%. Seeing the breakdown of DPI numbers both current and a year ago is some long overdue transparency.
The other positive is how UTHR's cost of goods sold has gone up substantially and a lot of that money will be flowing to MNKD for manufacturing costs. (Footnote: Cost of sales for the three months ended September 30, 2023 increased as compared to the same period in 2022, primarily due to an increase in Tyvaso DPI royalty expense and product costs following its commercial launch in June 2022.)
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Post by dh4mizzou on Nov 1, 2023 12:19:26 GMT -5
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Post by bthomas55ep on Nov 1, 2023 16:43:55 GMT -5
Estimated Q3 Q1 Q2 Q3
Afrezza 12,423 13,527 14,729 V-Go 5,139 4,818 5,000 Tyvaso 11,678 19,055 20,500 (10.0 % of UT's reported 205.1 sales) Coll & Svcs 11,386 11,211 11,300 Total 40,626 48,611 51,529 If so, MNKD revenue up a paltry 6% Maybe there is $5M or so lurking somewhere over in deferred income that can be pulled from the shelf to improve the picture. Hoping to see at least $56M for 3Q (to maintain a double digit 10+% growth quarter). 🤞 In reading the 3Q UTHR CC Transcript, I didn't get the same level of excitement they've seemed to have before about the rollout their DPI products. Their TETON study is using their nebulizer to get a consistent result between trials, while at the same time they are having discussions with the FDA about what it would take to get a DPI product available/approved for those indications later. Maybe/Probably they (UTHR) are staying patient because they know the constraints of mannkind are there anyway? Tempering their own expectations and realizing they have some time while they go about building their own plant makes the way the narrative is going seem reasonable. Also, when discussing the Tyvaso Nebulizer vs DPI this quarter, they said it was two-thirds DPI (which is good), but that the mix this quarter actually had a couple ticks towards more patients selecting to use the Nebulizer. Of course, they were agnostic to client preference and that they were just happy they were on a UTHR solution. I am probably reading too much into this slight trend due to my bias. Lastly, in the same ole vein there were some insurance issues with DPI this quarter/year that are believed to be resolved in 2024. Anyway, like many, I had those high expectations for another blow out Q over Q (riding on the back UTHR), but now I feel I need to temper my expectations for next week. At least we've got a few days to reset expectations (e.g. calm down as as Tswizzy might say) for something that will move the needle in 2023. Of course, still very confident in the longer term outcome and I do understand Mannkind has got to go through some growing pains. We have all, those that are left, gotten very good at being patient. Short of announcement like a UTHR second molecule, I think this Earnings call may just come and go like a thief in the night. Still hopeful and optimistic. GLTA. |
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Post by Chris-C on Nov 1, 2023 17:50:31 GMT -5
bthomas55ep : Thanks for your thoughts. It is exceedingly wise to temper expectations. Reading between the lines, I would speculate that: 1. Because of production, supply chain and insurance coverage headwinds, UTHR doesn't want to overstate its optimism and underperform its results going forward in the face of logistical snags. 2. UTHR wants to be a good corporate partner with MNKD and not be seen as blaming more modest DPI growth than forecast on MNKD. 3. Ticks toward nebulizer use are probably caused by the shortage of DPI. If you have PAH and Tyvaso will help improve your Quality of Life, you'll not hold out for the dreamboat if the nebulizer version is available now. 4. Finally, as with traffic jams created by crash bottlenecks, the production/supply chain issues will take a while to work through. Those opting for nebulizers may switch to the dreamboat later on, but the glitch runs straight to MNKD's revenue line. Somehow I seem to recall that MNKD has been guilty of constraining its revenue in the past because they underestimated demand. Do other long time investors here recall that? GLTAL Chris-C MNKD: The company where investor return is always a year away, regardless of how many years pass by. 
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Post by BD on Nov 1, 2023 22:58:11 GMT -5
So MNKD and TSLA (re. FSD) actually have something in common!
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Post by anderson on Nov 2, 2023 0:35:54 GMT -5
Total revenues, cost of sales, and gross profit (loss) for each of our commercial products and other were as follows (in millions):
Three Months Ended September 30,
2023 Tyvaso DPI(1) Nebulized Tyvaso(1)
Total revenues $ 205.1 $ 120.7
Cost of sales 31.1 9.8
Gross profit (loss) $ 174.0 $ 110.9
So is 31.1 the combined Royalties and collaborations and services? Last quarter
2023 Tyvaso(1)
Total revenues $ 318.9
Cost of sales 40.4
Gross profit (loss) $ 278.5 $
And MNKD received:
Revenue – collaborations and services11,211
Royalties – collaborations 19,055
Total 30266
So looks like it might be a million higher this quarter.
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Post by prcgorman2 on Nov 2, 2023 1:41:06 GMT -5
If we assume MNKD “collaborations and services” is proportional to UTHR “Cost of sales” QoQ, then we should expect about a 25% haircut QoQ of about $2.3M on 11,211.
If we assume 10% MNKD royalties on UTHR Tyvaso DPI then Q2 royalties implies UTHR revenue on Tyvaso DPI of about $190M. That means Q3 revenue was about $15M more than Q2, so about an extra $1.5M in royalties to MNKD.
The net would be about an $800K reduction in UTHR money to MNKD Q3 over Q2.
My assumptions about MNKD “C&S” proportinal to UTHR COS and royalty percentages aren’t that good so there could be more royalties and “c&s” flat or even up moderately. Steven Binder and Mike both said “C&S” revenue would be relatively flat. I’ve assumed that would be roughly true, especially if a big piece of the “C&S” accounting was labor.
I thought I remember UTHR suggesting $2B from Tyvaso within about 2 years of launch of DPI. I don’t know if the on-going UTHR trials for FDA approval of expanded indications for Tyvaso were part of that rosy prediction. If not, Q3 is a real puzzler. If yes, than go UTHR!
This puts a spotlight on clofazamine and to some degree, Afrezza, to help cement substantial profitability for MNKD and let them be less dependent on UTHR revenue for shareholder value. Someone recently said “next year” is always “next year”. It reminds me of the movie The Money Pit where every project would be complete in “two weeks”.
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Post by longliner on Nov 2, 2023 1:51:37 GMT -5
I appreciate as much as any shareholder here what you're saying PRC. I can't dispute the past. The current world we are in seems to have an M&A push going forward. We can extend patents, boost bottom lines (UTHR), the fact that our production is at capacity I struggle to find a negative with...I agree clofazamine is in the future, it has to be, we are at capacity for now, later will come. Or not. What an exciting few quarters Mannkind investors have to look forward to! All good.  |
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Post by agedhippie on Nov 2, 2023 8:05:28 GMT -5
... the fact that our production is at capacity I struggle to find a negative with...I agree clofazamine is in the future, it has to be, we are at capacity for now, later will come. Or not. What an exciting few quarters Mannkind investors have to look forward to! All good. This is why I don't see an issue with UTHR taking over manufacturing. In the Morgan Stanley call Mike talks about what he wants for MNKD and it's to become a biotech pharmaceutical company rather than rely on partnering and royalties. With that in mind recovering the manufacturing capacity is important as it allows this to happen. This part of the transcript is where he outlines his plan; We went through our growing pains and saying, what are we? Are we a platform company? Are we a licensing company? Are we just going to develop products and formulate and sell them off? And I think the way you really create value is to become a self-sustaining biotech pharmaceutical company.
And you look at the margins, and you look at the, while we can get royalties, that's great. At the end of the day, if you're a CMO, you're stuck in a very low-margin business, and you're on high-risk failure, and assets don't come along fast enough to sustain your company when you see these models. And so we really did pivot in 2019 to say, we are going to be fully focused on orphan lung, leverage our technology, help those patients.
That is better news for the future of Afrezza than the alternative (a royalty focus) as Afrezza now fits that model of owning the product from design to sales. It also sets the table for for going it alone with clofazamine and not using partners. The aim becomes to identify orphans where there little or no competition so the revenue stream is solid. This is also why GLP-1 would be a bad choice for MNKD, it's a heavily contested market and the domain of the big boys. |
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Post by celo on Nov 2, 2023 9:13:23 GMT -5
I appreciate as much as any shareholder here what you're saying PRC. I can't dispute the past. The current world we are in seems to have an M&A push going forward. We can extend patents, boost bottom lines (UTHR), the fact that our production is at capacity I struggle to find a negative with...I agree clofazamine is in the future, it has to be, we are at capacity for now, later will come. Or not. What an exciting few quarters Mannkind investors have to look forward to! All good. This quarter looks very unexciting as seen in the price. We could very well see an increase in losses and quite a degradation in stock price. Better make something special Mike or we gonna crumble. |
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Post by mnlearner on Nov 2, 2023 9:23:08 GMT -5
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Post by celo on Nov 2, 2023 9:34:35 GMT -5
Anybody have a theory why UTHR decided this quarter to reveal exactly the percent Mannkind makes? Low double digits, HA as Mannkind as shown several times they like to massage the truth. The LOWEST double digit looks to be the answer.
Maybe there will be a surprise decrease in expenses. One can only hope. Hope was Bobby Knight's least favorite word.
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Post by nemzter on Nov 2, 2023 9:35:18 GMT -5
So the big question - are we going to meet guidance for Q3, or are we pretty much screwed (not that we're not used to it already)? lol
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Post by ktim on Nov 2, 2023 9:56:34 GMT -5
So the big question - are we going to meet guidance for Q3, or are we pretty much screwed (not that we're not used to it already)? lol What guidance? |
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